Lead-MSAT (Validation) (Saudi Arabia)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Lead MS&T and validation activities supporting commercial manufacturing, technology transfer, and site readiness. Serve as the technical bridge across R&D, Technology Transfer, Production, Quality, and Engineering, driving the validation lifecycle (URS, FAT, SAT, IQ/OQ/PQ, re-qualification) and ensuring GMP documentation, data integrity, and ISO 14644 cleanroom qualification compliance. Review protocols/reports/risk assessments, lead investigations with RCA and CAPAs, and coordinate EQMS, calibration, and audit readiness.

Location: Saudi Arabia

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Sr. Manager level

Key Responsibilities

•Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness.
•Act as the technical bridge between R&D, Technology Transfer, Production, Quality, and Engineering while preparing/reviewing/approving and distributing validation documents.
•Maintain validation master plans and validation schedules, ensuring GMP documentation compliance and data integrity requirements.
•Execute and oversee the validation lifecycle using the V-Model approach (URS, FAT, SAT, IQ, OQ, PQ, re-qualification) for equipment, CSV, and systems (e.g., Water, utilities, HVAC, electricity, Thermal mapping).
•Lead investigations for process deviations/OOS/OOT and atypical results using scientific/statistical root cause analysis, propose CAPAs and process improvements, and support audit/regulatory inspection readiness.

Key Requirements

•Lead qualification and validation work in GMP-regulated pharmaceutical manufacturing environments, with 6–10 years of relevant experience and extensive hands-on validation capability.
•Strong practical knowledge of cGMP, SFDA, WHO, EU GMP, and ICH guidelines, including GMP documentation practices and regulatory inspection expectations.
•Hands-on expertise across the V-Model qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ), re-qualification, and periodic review programs.
•Demonstrated experience validating manufacturing equipment/production lines, critical utilities (PW, WFI, HVAC, compressed gases, nitrogen), and cleanrooms per ISO 14644.
•Experience with Computerized System Validation (CSV) and EQMS activities such as change control impact assessments, deviation investigations/RCA, CAPA development, and audit support.

Experience:6-10 yearsPharmaceutical manufacturingGMP-regulated environmentsValidationQualificationAseptic processingSterile/non-sterile manufacturing

Education:Bachelor's

Skills:AccountabilityCommunicationCollaborationTask planningRisk assessment

Tech Stack:V-ModelGMPCGMPSFDAWHOEU GMPICH guidelinesISO 14644IQOQPQFATSATURSCAPAALCOA+21 CFR Part 11MS OfficeEQMSElectronic QMS / validation management system

Company Brief

Julphar

Website

Loading job details...

Preparing the role view and application actions.

Julphar

2 days ago

Lead-MSAT (Validation) (Saudi Arabia)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Location: Saudi Arabia

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Sr. Manager level

Key Responsibilities

•Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness.
•Act as the technical bridge between R&D, Technology Transfer, Production, Quality, and Engineering while preparing/reviewing/approving and distributing validation documents.
•Maintain validation master plans and validation schedules, ensuring GMP documentation compliance and data integrity requirements.
•Execute and oversee the validation lifecycle using the V-Model approach (URS, FAT, SAT, IQ, OQ, PQ, re-qualification) for equipment, CSV, and systems (e.g., Water, utilities, HVAC, electricity, Thermal mapping).
•Lead investigations for process deviations/OOS/OOT and atypical results using scientific/statistical root cause analysis, propose CAPAs and process improvements, and support audit/regulatory inspection readiness.

Key Requirements

•Lead qualification and validation work in GMP-regulated pharmaceutical manufacturing environments, with 6–10 years of relevant experience and extensive hands-on validation capability.
•Strong practical knowledge of cGMP, SFDA, WHO, EU GMP, and ICH guidelines, including GMP documentation practices and regulatory inspection expectations.
•Hands-on expertise across the V-Model qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ), re-qualification, and periodic review programs.
•Demonstrated experience validating manufacturing equipment/production lines, critical utilities (PW, WFI, HVAC, compressed gases, nitrogen), and cleanrooms per ISO 14644.
•Experience with Computerized System Validation (CSV) and EQMS activities such as change control impact assessments, deviation investigations/RCA, CAPA development, and audit support.

Experience:6-10 yearsPharmaceutical manufacturingGMP-regulated environmentsValidationQualificationAseptic processingSterile/non-sterile manufacturing

Education:Bachelor's

Skills:AccountabilityCommunicationCollaborationTask planningRisk assessment

Tech Stack:V-ModelGMPCGMPSFDAWHOEU GMPICH guidelinesISO 14644IQOQPQFATSATURSCAPAALCOA+21 CFR Part 11MS OfficeEQMSElectronic QMS / validation management system

Company Brief

Julphar

Website